MANIFEST-2_NZA68438
Study of CPI-0610 in Myelofibrosis (MF) (MANIFEST-2)
Trial summary:
A Phase 3, randomized, blinded study comparing CPI-0610 and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been exposed previously to Janus kinase inhibitors (JAKi).
Receptor status / problem studied:
Essential Thrombocythaemia/ Myelofibrosis/ Polycythaemia
Inclusion criteria
- Aged ≥ 18 years
- Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia)
- Adequate hematologic, renal, and hepatic function
- Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0
- Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system
- Spleen volume of ≥ 450 cm^3
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Exclusion criteria
- Splenectomy or splenic irradiation in the previous 6 months
- Chronic or active conditions and/or concomitant medication use that would prohibit treatment
- Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm
Open for recruitment
Trial Title
MANIFEST-2 CP-0610-04
Diagnosis
Myeloproliferative disorders
Type of trial
Pharmaceutical
Type of treatement
Haematology
Phase
III
Locations
Investigators
Principal Investigator